510(k) K983618 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE
| Applicant | Rockwell Medical Technologies, Inc., Wixom MI, US |
| Decision | Substantially Equivalent, Aug 5, 1999 |
| Received | Oct 15, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983618
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.